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For New York Specimens

New York State Non-Permitted Laboratory Test Request

Under New York State Public Health Law (Article 5, Title V, Section 574) and regulations (Part 58-
1.10 (g) of 10NYCRR), laboratories performing testing for any specimens collected in the State of
New York must hold a New York State clinical laboratory permit or have test request approval for
specific tests. PreventionGenetics holds a New York State Department of Health Clinical Laboratory Permit for several tests. Please check this page regularly as we are in the process of applying for
permits for many additional tests.

New York State Non-Permitted Laboratory Test Request

Because of the rarity of many genetic conditions, testing may not be available through a permit-
holding laboratory, or there may be justification for sending to a non-permitted laboratory. New York
State approval must be obtained before sending the specimen to a non-permitted laboratory. The
ordering provider requesting testing must document that the patient or legal guardian was informed
that the laboratory performing the testing does not hold a New York State laboratory permit or that the
test is not approved by the Department.

For all tests not included in the list above, you must first submit a completed Non-Permitted Laboratory Test Request Approval Form to the New York State Health Department and receive approval for any patient specimen collected in New York that you wish to send to our laboratory for
testing. Upon approval, you may send the patient specimen, test requisition form, and a copy of the
approval letter for testing to commence.

Notification of approval or rejection will be sent in writing for each request to use a non-permitted
laboratory. If rejected, the reason(s) for denial will be explained in the written response. Please
contact the Clinical Laboratory Evaluation Program at (518) 485-5378 with any questions.